Background and Aim Although treatment with direct-acting antivirals has dramatically improved morbidity and mortality attributable to chronic hepatitis C virus infection, universal access to these medicines has been slow in the Asia-Pacific region and Russia. This study evaluated efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus infection from Asia-Pacific countries and Russia (C-CORAL). Methods C-CORAL was a phase 3, randomized, placebo-controlled study (NCT02251990). Treatment-naive, HIV-negative, cirrhotic and non-cirrhotic participants with chronic hepatitis C genotype 1, 4, or 6 infection were randomized to elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks (immediate-treatment group) or placebo followed by deferred treatment with elbasvir/grazoprevir (deferred-treatment group). The primary efficacy outcome was sustained virologic response at 12 weeks, and the primary safety outcome was a comparison between the immediate-treatment group and placebo phase of the deferred-treatment group. Results A total of 489 participants were randomized (immediate-treatment group, n = 366; deferred-treatment group, n = 123). Sustained virologic response at 12 weeks in the combined immediate/deferred-treatment groups was 94.4% (459/486; 95% confidence interval = 92.4-96.5%). Sustained virologic response at 12 weeks was 98.2% in participants with genotype 1b, 91.9% with genotype 1a, and 66.7% with genotype 6 infection. Similar rates of adverse events and drug-related adverse events were seen in the immediate-treatment group versus placebo phase of the deferred-treatment group (51.0% vs 50.4% and 21.4% vs 21.1%). Conclusions Elbasvir/grazoprevir for 12 weeks represents an effective and well-tolerated treatment option for treatment-naive people with genotype 1 infection from Asia-Pacific countries and Russia.
[1]Peking Univ, Peoples Hosp, Hepatol Inst, Beijing Key Lab Hepatitis & Immunotherapy Liver D, 11 Xizhimen South St, Beijing 100044, Peoples R China.
[2]Capital Med Univ, Beijing Friendship Hosp, Beijing Key Lab Translat Med Cirrhosis, Liver Res Ctr,Natl Clin Res Ctr Digest Dis, Beijing, Peoples R China.
[3]Beijing 302 Hosp, Treatment & Res Ctr Infect Dis, Beijing, Peoples R China.
[4]Merck Sharp & Dohme Ltd, Beijing, Peoples R China.
[5]Capital Med Univ, Beijing YouAn Hosp, Artificial Liver Ctr, Beijing, Peoples R China.
[6]Jilin Univ, Hosp 1, Dept Hepatol, Changchun, Jilin, Peoples R China.
[7]Merck & Co Inc, Kenilworth, NJ USA.
[8]Mil Med Acad, St Petersburg, Russia.
[9]Fed Res Ctr Nutr & Biotechnol, Dept Gastroenterol & Hepatol, Moscow, Russia.
[10]Natl Cheng Kung Univ, Tainan, Taiwan.
[11]Siriraj Hosp, Dept Med, Fac Med, Bangkok, Thailand.
[12]Natl Hosp Trop Dis, Hanoi, Vietnam.
[13]Pusan Natl Univ, Coll Med, Busan, South Korea.
[14]Pusan Natl Univ Hosp, Med Res Inst, Busan, South Korea.
[15]Westmead Hosp, Westmead Inst Med Res, Storr Liver Ctr, Westmead, NSW, Australia.
[16]Univ Sydney, Westmead, NSW, Australia.
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